Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine (EBEREST)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00640588

First received: March 17, 2008

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 17, 2008

Last Updated Date

May 7, 2012

Start Date ^ICMJE

March 2008

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks [ Time Frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00640588 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline [ Time Frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

Official Title ^ICMJE

Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine

Brief Summary

This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Hepatitis B, Chronic

Intervention ^ICMJE

Drug: Telbivudine
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
Other Names:
- Sebivo
- Tyzeka
- Hepsera
Drug: oral adefovir
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Other Name: adefovir

Study Arm (s)

Experimental: 1
Telbivudine

Intervention: Drug: Telbivudine
Active Comparator: 2
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Intervention: Drug: oral adefovir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, at least 18 years of age.
Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

Exclusion Criteria:

Co-infection with HCV, HDV, or HIV.
Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
History of hepatic decompensation
History of malignancy
Patient has one or more additional known primary or secondary causes of liver disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00640588

Other Study ID Numbers ^ICMJE

CLDT600AES01

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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